XtraCare Oatmeal Daily Moisturizing 8 oz

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: XtraCare Oatmeal Daily Moisturizing 8 oz
Generic name: DIMETHICONE
Manufacturer: Rejoice International Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c055d5fb-7398-26e4-e053-2995a90acd41
SPL ID: 2e12de28-f85b-9518-e063-6394a90ae58f
Version: 2
Effective date: 2025-02-13
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/8ec9b1418c25a8bb472a36e6bc0b2cbabb210d48d5dd734197e022d21529ed58/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:15:18

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		XtraCare Oatmeal Daily Moisturizing 8 oz	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Rejoice International Inc.	openfda.manufacturer_name
ndc	package	57337-138-01	openfda.package_ndc
ndc	product	57337-138	openfda.product_ndc
ndc11	package	57337013801	derived:openfda.package_ndc
rxcui		891710	openfda.rxcui
spl id		2e12de28-f85b-9518-e063-6394a90ae58f	id
spl set id		c055d5fb-7398-26e4-e053-2995a90acd41	set_id
unii		92RU3N3Y1O	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only When using this product avoid contact with eyes. In case of eye contact, flush with water. Do not use on deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.